IMFINZI Is First Immunotherapy to Show Both Significant Survival Benefit and Improved, Durable Responses in Extensive-Stage Small Cell Lung Cancer

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In the Phase III CASPIAN trial IMFINZI at a fixed, convenient dose improved survival with either a cisplatin or carboplatin chemotherapy backbone

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca today presented detailed results from the Phase III CASPIAN trial, showing IMFINZI® (durvalumab) significantly improved overall survival (OS) in patients with previously-untreated extensive-stage small cell lung cancer (SCLC).

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IMFINZI in combination with four cycles of standard-of-care (SoC) chemotherapy (etoposide with either cisplatin or carboplatin) demonstrated a statistically-significant and clinically-meaningful improvement in OS vs. SoC chemotherapy consisting of up to six cycles of chemotherapy and optional prophylactic cranial irradiation (PCI).

The risk of death was reduced by 27% (equal to a hazard ratio of 0.73), with median OS of 13.0 months for IMFINZI plus chemotherapy vs. 10.3 months for SoC chemotherapy. Results showed an OS benefit with an estimated 33.9% of patients alive at 18 months following treatment with IMFINZI plus chemotherapy vs. 24.7% of patients following SoC chemotherapy.

Across all efficacy endpoints, benefits were observed in patients treated with IMFINZI plus chemotherapy vs. SoC chemotherapy. Results showed a higher progression-free survival (PFS) rate at 12 months (17.5% vs. 4.7%), a 10.3% increase in confirmed objective response rate (ORR) (67.9% vs. 57.6%), and improved duration of response (DOR) at 12 months (22.7% vs. 6.3%).

The results were presented at the Presidential Symposium of the IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain.

José Baselga, Executive Vice President, Oncology R&D said: “We are encouraged to see more than a third of small cell lung cancer patients treated with IMFINZI plus chemotherapy alive at the 18-month landmark, which is remarkable given the aggressive nature of the disease. It is also noteworthy that these results may enable physicians to choose IMFINZI in combination with either cisplatin or carboplatin chemotherapy backbones. We look forward to working with regulatory authorities to bring IMFINZI to patients with small cell lung cancer around the world as soon as possible.”

Luis Paz-Ares, MD, Ph.D., Chair, Medical Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain and principal investigator in the Phase III CASPIAN trial said: “Patients have had limited treatment options for small cell lung cancer, a devastating disease where the five-year survival rate has been as low as 6%. The significant survival benefit demonstrated with IMFINZI combined with only four cycles of a choice of chemotherapy compared to a robust control arm, provides evidence and hope of a new treatment option for these patients.”

SCLC is an aggressive, fast-growing cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy.

This is the first study to show efficacy of using a fixed dose of IMFINZI (1500mg) administered every 3 weeks while in combination with chemotherapy for 4 cycles and then every 4 weeks until disease progression.

Summary of results

 

EP + IMFINZIi

(n=268)

EPi

(n=269)

OS (primary endpoint)ii

 

Number of deaths (%)

155 (57.8%)

181 (67.3%)

Hazard ratio

(95% CI)

0.73 (0.591, 0.909)

p-value

0.0047

Median in months

(95% CI)

13.0

(11.5, 14.8)

10.3

(9.3, 11.2)

OS rate (18 months)

33.9%

24.7%

PFS (secondary endpoint)ii,iii

 

Number (%) of patients with event

226 (84.3%)

233 (86.6%)

Hazard ratio

(95% CI)

0.78 (0.645, 0.936)

Median in months

(95% CI)

5.1

(4.7, 6.2)

5.4

(4.8, 6.2)

PFS rate (12 months)

17.5%

4.7%

ORR (secondary endpoint)ii,iv

 

Number (%) of patients with response

182 (67.9%)

155 (57.6%)

Odds ratio

(95% CI)

1.56 (1.095, 2.218)

DOR at 12 months (secondary endpoint)

22.7%

6.3%

i

Etoposide plus investigator choice of cisplatin or carboplatin chemotherapy.

ii

The data cut-off date for analysis of OS, PFS and ORR was March 11, 2019.

iii

PFS was not formally tested for statistical significance.

iv

Confirmed responses according to investigator assessment per RECIST v1.1.

The safety and tolerability of IMFINZI in combination with SoC etoposide and platinum-based chemotherapy was consistent with previous trials. Results showed that 61.5% of patients experienced a Grade 3 or 4 AE with IMFINZI plus SoC chemotherapy (all causes) vs. 62.4% with SoC chemotherapy, and patients discontinuing treatment due to AEs were similar between arms (9.4% vs. 9.4%).

IMFINZI is also being tested following concurrent chemoradiation therapy in limited-stage SCLC in the Phase III ADRIATIC trial.

This data adds to IMFINZI’s already compelling data in lung cancer which is already approved in the curative-intent setting of unresectable, Stage III non-small cell lung cancer after chemoradiotherapy based on the Phase III PACIFIC trial.

IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI® (durvalumab).

IMFINZI can cause serious, potentially fatal adverse reactions including immune-mediated pneumonitis, hepatitis, colitis or diarrhea, endocrinopathies, nephritis, rash or dermatitis, other immune-mediated adverse reactions, infection, and infusion-related reactions. Please refer to the full Prescribing Information for important dosage modification and management information specific to adverse reactions.

Immune-Mediated Pneumonitis

IMFINZI can cause immune-mediated pneumonitis, defined as requiring use of corticosteroids. Fatal cases have been reported. Monitor patients for signs and symptoms of pneumonitis and evaluate with radiographic imaging when suspected. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold IMFINZI for Grade 2 pneumonitis; permanently discontinue for Grade 3 or 4 pneumonitis.

In clinical studies enrolling 1889 patients with various cancers who received IMFINZI, pneumonitis occurred in 5% of patients, including Grade 3 (0.8%), Grade 4 (

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